NCT00779740

Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray (Study P04419)

Clinical Equivalency Study of Two Formulations of Mometasone Furoate Nasal Spray

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate \[MF\] in 50 μL of solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in patients with perennial allergic rhinitis.

Conditions

• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	mometasone furoate	The dose will be 50 mcg as MF in one spray (100 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.
DRUG	mometasone furoate	The dose will be 50 mcg as MF in one spray (50 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg.

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2008-10-24
• Last updated: 2024-08-15